Xeno­trans­plan­ta­tion is hav­ing a mo­ment.

Last Oc­to­ber, a team from NYU suc­cess­ful­ly trans­plant­ed a kid­ney from a pig in­to a brain-dead pa­tient, al­though ob­servers cast doubt on the im­por­tance of the ex­per­i­ment. Then, ear­li­er this month, sur­geons at the Uni­ver­si­ty of Mary­land trans­plant­ed a pig heart in­to a dy­ing hu­man, who ap­pears to still be sta­ble.

Jayme Locke

Now, an­oth­er group is plant­i­ng a flag in the xeno­trans­plan­ta­tion field. Sur­geons at the Uni­ver­si­ty of Al­aba­ma at Birm­ing­ham said Thurs­day they have achieved the first kid­ney trans­plant from a pig to a brain-dead pa­tient, pub­lish­ing their peer-re­viewed find­ings on­line. The team, aim­ing to dif­fer­en­ti­ate it­self from the oth­ers through the ge­net­ic mod­i­fi­ca­tions used, is hop­ing there’s now enough re­search to soon be­gin clin­i­cal xeno­trans­plan­ta­tion stud­ies.

“We have bridged crit­i­cal knowl­edge gaps and ob­tained the safe­ty and fea­si­bil­i­ty da­ta nec­es­sary to be­gin a clin­i­cal tri­al in liv­ing hu­mans with end-stage kid­ney fail­ure dis­ease,” said Jayme Locke, di­rec­tor of the UAB surgery de­part­ment’s trans­plan­ta­tion in­sti­tute, in pre­pared re­marks.

The com­mon thread through all these trans­plan­ta­tion ef­forts? That would be Unit­ed Ther­a­peu­tics’ Re­vivi­cor, which sup­plied the or­gans to each of the aca­d­e­m­ic teams in ques­tion. The biotech’s ge­net­i­cal­ly al­tered pigs were ap­proved by the FDA in De­cem­ber 2020 for use in food and po­ten­tial ther­a­peu­tic us­es.

Each of the Re­vivi­cor or­gans used con­tained ge­net­ic mod­i­fi­ca­tions, but the NYU pro­ce­dure on­ly in­clud­ed the elim­i­na­tion of a cer­tain sug­ar from the or­gan’s sur­face, with the goal of re­duc­ing the body’s re­jec­tion re­sponse. The Mary­land and UAB teams, mean­while, used or­gans con­tain­ing at least 10 dif­fer­ent ge­net­ic mod­i­fi­ca­tions.

Like the Mary­land team, UAB re­searchers trans­plant­ed the or­gan in­side the pa­tient’s body, where­as NYU on­ly su­tured the kid­ney to the pa­tient’s leg. UAB, though, con­duct­ed its pro­ce­dure on a brain-dead pa­tient as NYU did, while Mary­land trans­plant­ed the pig heart in­to a ter­mi­nal­ly ill man.

Giv­en the mas­sive short­age of avail­able or­gans for pa­tients who need trans­plants, sci­en­tists have for years the­o­rized how to safe­ly and ef­fec­tive­ly make xeno­trans­plan­ta­tion work. In ad­di­tion to Re­vivi­cor, bio­phar­mas such as Tec­tor, eGe­n­e­sis and Qi­han Biotech are work­ing to de­vel­op ready-made or­gans.

In par­tic­u­lar, eGe­n­e­sis proved the ear­ly VC fa­vorite, win­ning back­ing from promi­nent firms like Bay­er’s in­vest­ment arm and Far­al­lon, in ad­di­tion to Har­vard. But the com­pa­ny is still wait­ing to hold a pre-IND meet­ing with the FDA, eGe­n­e­sis spokesper­son David Carmel told End­points News. And though eGe­n­e­sis has ac­quired the nec­es­sary pathogen-free fa­cil­i­ty that Carmel said meets all FDA cri­te­ria, reg­u­la­tors have yet to in­spect it and like­ly won’t do so un­til the com­pa­ny is ready to make a prod­uct that can be put in­to hu­mans.

Kid­neys in par­tic­u­lar could be a po­ten­tial gold mine for com­pa­nies able to breed ge­net­i­cal­ly mod­i­fied pigs and a re­lief for pa­tients and their fam­i­lies. More than 800,000 Amer­i­cans are liv­ing with kid­ney fail­ure and most nev­er re­ceive a donor’s kid­ney. That can re­sult in in­ten­sive and ex­cru­ci­at­ing dial­y­sis treat­ments, sharply re­duc­ing pa­tients’ qual­i­ty of life.

Up­date: This ar­ti­cle has been up­dat­ed with com­ment from eGe­n­e­sis.

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